Sponsors (4)
Last progress June 12, 2025 (8 months ago)
Introduced on June 12, 2025 by Gary C. Peters
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Creates a new HHS program to contract with qualified entities to build and maintain reserves and surge production capacity for critical drugs and active pharmaceutical ingredients whose supply chains are vulnerable. Participating entities must hold inventories (generally a 6‑month reserve or another Secretary‑determined level), be able to ramp or shift production on the Secretary’s direction, and allow transfer or allocation of reserves during emergencies; the bill requires HHS guidance within 180 days, biennial reports to Congress after the first award, and authorizes $500 million for FY2026.
Authorizes $500,000,000 to be appropriated for fiscal year 2026 to carry out this section.
Authorizes the Secretary of Health and Human Services to award contracts or cooperative agreements to eligible entities for drugs and active pharmaceutical ingredients that the Secretary determines are critical and have vulnerable supply chains; the Secretary must publish the list of such drugs and ingredients.
An eligible entity receiving an award must maintain, in a satisfactory domestic establishment registered under section 510(b) of the FD&C Act or an OECD-country foreign establishment registered under section 510(i), a 6-month reserve (or other reasonable quantity as determined by the Secretary) of: (i) the active pharmaceutical ingredient specified in the contract, regularly replenished with recently manufactured supply, and (ii) the finished eligible drug product specified in the contract, regularly replenished with a recently manufactured supply.
An eligible entity must implement production of the eligible drug or its active pharmaceutical ingredient at the direction of the Secretary, under the terms and quantities specified in the contract or cooperative agreement.
An eligible entity must enter into an arrangement agreeing to transfer a portion of the maintained active pharmaceutical ingredient reserve to another manufacturer if the Secretary determines more finished drug product is needed and the original entity cannot use its reserve to make enough product.
Who is affected and how:
Drug manufacturers and pharmaceutical companies: Directly affected as likely program participants and award recipients; they would build or maintain reserve inventories and may invest or repurpose capacity to meet contract terms. They must accept operational directions from HHS and commit to supply sharing under emergency conditions.
Pharmacies, wholesalers, and distributors: Indirectly affected because improved reserves and surge capacity can reduce the frequency and severity of shortages, stabilizing supply chains and distribution planning.
Health care providers and hospitals: Benefit from greater drug availability during shortages or public health emergencies, which can improve clinical continuity and reduce the need for rationing or substitution.
Patients and the public (consumers): Likely to experience fewer interruptions in access to critical medications, particularly for drugs with fragile or concentrated supply chains.
Department of Health and Human Services (program administration): Responsible for issuing guidance, selecting qualified entities, overseeing contracts/cooperative agreements, directing production in crises, and reporting to Congress. This creates administrative workload and oversight responsibilities within HHS.
Potential tradeoffs and considerations:
Program success depends on selecting capable partners and setting appropriate inventory levels and contract terms; too-small reserves or weak enforcement could limit impact.
Private participants may need to make capital and operating investments to meet reserve and surge requirements; contract terms will influence willingness to participate.
The authorization provides funding capacity but actual appropriations and the timing of award decisions will determine how quickly the program affects supply resilience.
RAPID Reserve Act
Updated 3 days ago
Last progress June 12, 2025 (8 months ago)